{"id":134044,"date":"2025-09-30T10:29:13","date_gmt":"2025-09-30T08:29:13","guid":{"rendered":"https:\/\/obera.fr\/nase-rada\/farmacijos-pramone-dulkejimo-ir-poveikio-kontrole-sveriant-ir-perkeliant-hpapi\/"},"modified":"2025-11-27T21:25:04","modified_gmt":"2025-11-27T19:25:04","slug":"farmacijos-pramone-dulkejimo-ir-poveikio-kontrole-sveriant-ir-perkeliant-hpapi","status":"publish","type":"post","link":"https:\/\/obera.fr\/lt\/farmacijos-pramone\/farmacijos-pramone-dulkejimo-ir-poveikio-kontrole-sveriant-ir-perkeliant-hpapi\/","title":{"rendered":"Farmacijos pramon\u0117: dulk\u0117jimo ir poveikio kontrol\u0117 sveriant ir perkeliant HPAPI"},"content":{"rendered":"\n<p>HPAPI (Highly Potent Active Pharmaceutical Ingredients \u2013 labai stipr\u016bs veiklieji farmaciniai ingredientai) augimas i\u0161 esm\u0117s kei\u010dia <strong>farmacijos gamybos praktik\u0105<\/strong>. \u0160ios molekul\u0117s (citotoksin\u0117s, hormonin\u0117s, prie\u0161v\u0117\u017ein\u0117s, antivirusin\u0117s) pasi\u017eymi dideliu terapiniu aktyvumu, bet taip pat kelia <a href=\"https:\/\/obera.fr\/lt\/musu-patarimas\/substances-cmr-risque-exposition-au-travail-quelle-reglementation-prevention\/\">didel\u0119 toksikologin\u0119 rizik\u0105<\/a> darbuotojams ir aplinkai.<\/p>\n\n<h2 class=\"wp-block-heading\">I\u0161\u0161\u016bkiai ir praktin\u0117s problemos<\/h2>\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<p>Milteli\u0173 sv\u0117rimo ir perk\u0117limo etapai yra ypa\u010d kriti\u0161ki: net ma\u017ei kiekiai gali <strong>sukurti ore esan\u010dias koncentracijas<\/strong>, vir\u0161ijan\u010dias profesinio poveikio ribas (OEL).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Netinkamos kontrol\u0117s pasekm\u0117s:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>operatori\u0173 ekspozicija (kv\u0117pavimo tak\u0173 ligos, sisteminiai poveikiai);<\/li>\n\n\n\n<li>kry\u017emin\u0117 kit\u0173 produkt\u0173 ar partij\u0173 tar\u0161a;<\/li>\n\n\n\n<li>kokyb\u0117s nuokrypiai, net partij\u0173 at\u0161aukimai;<\/li>\n\n\n\n<li>sustabdymai ar sankcijos d\u0117l GMP\/EHS neatitikim\u0173.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">HPAPI sv\u0117rimo patalp\u0173 auditai atskleid\u017eia:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>pakartotin\u012f dulki\u0173 susidarym\u0105 i\u0161krovimo, sijojimo ar perk\u0117limo metu;<\/li>\n\n\n\n<li>nuot\u0117kius per sandariklius, bunkerius, vo\u017etuvus ir konteinerius;<\/li>\n\n\n\n<li>sud\u0117ting\u0105 prie\u017ei\u016br\u0105 (filtr\u0173 u\u017esikim\u0161imas, pavir\u0161i\u0173 valymas), kuri prailgina prastov\u0173 laik\u0105;<\/li>\n\n\n\n<li>izoliavimo sunkumus kei\u010diant partijas ir atliekant rankines operacijas.<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/industrie-pharmaceutique-1024x1024.webp\" alt=\"farmacijos pramon&#x117;\" class=\"wp-image-129371\" srcset=\"https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/industrie-pharmaceutique-1024x1024.webp 1024w, https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/industrie-pharmaceutique-300x300.webp 300w, https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/industrie-pharmaceutique-150x150.webp 150w, https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/industrie-pharmaceutique-768x768.webp 768w, https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/industrie-pharmaceutique.webp 1080w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n<\/div>\n<\/div>\n\n<p>\u012eprastin\u0117s priemon\u0117s (paprasta bendroji ventiliacija ar nuotolinis surinkimas) yra nepakankamos <strong>u\u017etikrinti daleli\u0173 lygio palaikym\u0105<\/strong>, atitinkant\u012f tikslines OEL (&lt; 1 \u03bcg\/m3 ar net &lt; 0,1 \u03bcg\/m3 pagal OEB).<\/p>\n\n<h2 class=\"wp-block-heading\">Tradicini\u0173 praktik\u0173 ribotumai<\/h2>\n\n<h3 class=\"wp-block-heading\">Kai kurie padaliniai ir toliau remiasi:<\/h3>\n\n<ul class=\"wp-block-list\">\n<li>skiedimo ventiliacija (HVAC) be tiesioginio surinkimo;<\/li>\n\n\n\n<li>atviromis traukomis ar paprastomis kabinomis su u\u017esikim\u0161usiais ar blogai \u012frengtais filtrais;<\/li>\n\n\n\n<li>reguliariai netikrintais filtrais arba \u017eemesn\u0117s nei H13 klas\u0117s filtrais.<\/li>\n<\/ul>\n\n<p>\u0160ie sprendimai neleid\u017eia pasiekti \u017eem\u0173 OEL ir <strong>operatoriai patiria poveik\u012f dinaminiuose etapuose<\/strong> (statin\u0117s atidarymas, sv\u0117rimas, perk\u0117limas).<\/p>\n\n<h2 class=\"wp-block-heading\">OberA sprendimas: ePURBOX BRS (ATEX)<\/h2>\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<h3 class=\"wp-block-heading\">Surinkimas prie \u0161altinio, maksimalus artumas<\/h3>\n\n\n\n<p>Vienas i\u0161 pagrindini\u0173 <strong>tar\u0161os kontrol\u0117s<\/strong> princip\u0173 yra dulki\u0173 surinkimas j\u0173 susidarymo vietoje. EpurBox BRS galimyb\u0117 b\u016bti pastatytam labai arti sv\u0117rimo ta\u0161ko (ar bunkerio) riboja pakartotin\u012f dulki\u0173 susidarym\u0105, ma\u017eina j\u0173 sklaid\u0105 dirbtuv\u0117se ir suma\u017eina apkrov\u0105 kitiems <strong>ventiliacijos sistemoms<\/strong>. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Lankstumas daugiaproduktiniam ar bandomajam naudojimui<\/h3>\n\n\n\n<p>Gamyklose, kuriose naudojamos kelios molekul\u0117s arba vystymo\/bandomajame etape, gali b\u016bti neprakti\u0161ka <strong>\u012frengti fiksuot\u0105 sistem\u0105<\/strong> kiekvienam sv\u0117rimo ta\u0161kui. EpurBox BRS leid\u017eia naudoti &#8222;pagal poreik\u012f&#8221;: jis atne\u0161amas, kai vyksta operacija, tada perkeliamas. Tai riboja <strong>fiksuotas investicijas,<\/strong> didina lankstum\u0105 ir ma\u017eina rizikos zonas.  <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Rankini\u0173 operacij\u0173 saugumo u\u017etikrinimas<\/h3>\n\n\n\n<p>Atliekant rankines u\u017eduotis, tokias kaip statini\u0173 atidarymas, dozavimas ar perk\u0117limas per piltuv\u0105, EpurBox BRS gali b\u016bti pastatytas taip, kad <strong>surinkt\u0173 dulki\u0173 srautus<\/strong>, i\u0161siskirian\u010dius \u0161i\u0173 manipuliacij\u0173 metu, ma\u017eindamas operatoriaus momentin\u0119 ekspozicij\u0105.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">ATEX atitiktis aplinkoje su degiomis dulk\u0117mis<\/h3>\n\n\n\n<p>ATEX sertifikuotas EpurBox BRS yra pritaikytas klasifikuotoms zonoms (pvz., 22 zonai dulk\u0117ms). Tai leid\u017eia <a href=\"https:\/\/obera.fr\/lt\/farmacijos-pramone\/\">farmacijos \u012fmon\u0117ms<\/a>, kurios <strong>dirba su galimai degiomis dulk\u0117mis<\/strong> (organiniais u\u017epildais, cukrumi, laktoze ir kt.), j\u012f naudoti nepa\u017eeid\u017eiant saugos zon\u0173 reikalavim\u0173. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Lengvas kvalifikavimas ir eksploatacija<\/h3>\n\n\n\n<p>Prireikus keisti filtr\u0105, d\u0117\u017e\u0117 gali b\u016bti izoliuota\/depresurizuota, ribojant i\u0161metimus.<\/p>\n\n\n\n<p>D\u0117\u017e\u0117 leid\u017eia <strong>dokumentuoti savo veikim\u0105<\/strong> (srautus, sl\u0117gius, filtravimo efektyvum\u0105) IQ\/OQ\/PQ kontekste.<\/p>\n\n\n\n<p>Diferencinio sl\u0117gio steb\u0117jimas, \u012fsp\u0117jimai ir planin\u0117 prie\u017ei\u016bra u\u017etikrina kontroliuojam\u0105 eksploatacij\u0105.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/visuel-epurbox-brs-1024x1024.png\" alt=\"epurbox brs vaizdas\" class=\"wp-image-129394\" srcset=\"https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/visuel-epurbox-brs-1024x1024.png 1024w, https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/visuel-epurbox-brs-300x300.png 300w, https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/visuel-epurbox-brs-150x150.png 150w, https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/visuel-epurbox-brs-768x768.png 768w, https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/visuel-epurbox-brs.png 1200w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n<\/div>\n<\/div>\n\n<h2 class=\"wp-block-heading\">\u012egyvendinimo scenarijus: tipinis naudojimo atvejis<\/h2>\n\n<h3 class=\"wp-block-heading\">Paimkime konkret\u0173 pavyzd\u012f:<\/h3>\n\n<ul class=\"wp-block-list\">\n<li>Farmacijos \u012fmon\u0117 turi pasverti HPAPI su OEB = 4 (tikslin\u0117 OEL ~ 1 \u03bcg\/m3) bandomojoje laboratorijoje. <\/li>\n\n\n\n<li>EpurBox BRS yra pastatytas \u0161alia svarstykli\u0173 su <strong>siurbimo ranka ar antgaliu, nukreiptu \u012f sv\u0117rimo zon\u0105<\/strong>. <\/li>\n\n\n\n<li>\u012erenginys veikia, milteliai \u0161iek tiek i\u0161siskiria pad\u0117jimo ar perk\u0117limo metu: EpurBox susiurbia vietoje, gr\u0105\u017eindamas filtruot\u0105 or\u0105 \u012f dirbtuves arba \u012f speciali\u0105 i\u0161metimo sistem\u0105. <\/li>\n\n\n\n<li>Operacijos metu stebimas diferencinis sl\u0117gis: jei filtras u\u017esikem\u0161a, \u012fsijungia \u012fsp\u0117jimas d\u0117l keitimo\/valymo. <\/li>\n\n\n\n<li>Po naudojimo EpurBox gali b\u016bti perkeltas \u012f kit\u0105 linij\u0105 arba pad\u0117tas \u012f bud\u0117jimo re\u017eim\u0105.<\/li>\n<\/ul>\n\n<p>Su \u0161iuo \u012frenginiu <strong>dirbtuv\u0117ms nereikia \u012frengti stacionari\u0173 traukos spint\u0173<\/strong> prie kiekvienos darbo vietos, ir jos turi efektyv\u0173 mobil\u0173 izoliavimo \u012frank\u012f.<\/p>\n\n<p>Nor\u0117dami susipa\u017einti su m\u016bs\u0173 produktais ir kartu sukurti J\u016aS\u0172 erdv\u0117ms pritaikyt\u0105 sprendim\u0105, susisiekite su m\u016bs\u0173 komandomis. Mes pad\u0117sime jums i\u0161sirinkti <strong>tinkamiausius \u012frenginius<\/strong> pagal j\u016bs\u0173 apribojimus ir tikslus. <\/p>\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-a89b3969 wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/obera.fr\/lt\/contact\/\">Susisiekite su mumis<\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>HPAPI (Highly Potent Active Pharmaceutical Ingredients \u2013 ypa\u010d stipr\u016bs farmacijos veiklieji ingredientai) pl\u0117tra i\u0161 esm\u0117s kei\u010dia farmacijos gamybos praktik\u0105.<\/p>\n","protected":false},"author":13,"featured_media":83744,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_seopress_robots_primary_cat":"none","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","footnotes":""},"categories":[891],"tags":[892],"class_list":["post-134044","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-farmacijos-pramone","tag-mobilus-pjedestalai","generate-columns","tablet-grid-50","mobile-grid-100","grid-parent","grid-50","no-featured-image-padding","resize-featured-image"],"acf":[],"_links":{"self":[{"href":"https:\/\/obera.fr\/lt\/wp-json\/wp\/v2\/posts\/134044","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/obera.fr\/lt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/obera.fr\/lt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/obera.fr\/lt\/wp-json\/wp\/v2\/users\/13"}],"replies":[{"embeddable":true,"href":"https:\/\/obera.fr\/lt\/wp-json\/wp\/v2\/comments?post=134044"}],"version-history":[{"count":1,"href":"https:\/\/obera.fr\/lt\/wp-json\/wp\/v2\/posts\/134044\/revisions"}],"predecessor-version":[{"id":134046,"href":"https:\/\/obera.fr\/lt\/wp-json\/wp\/v2\/posts\/134044\/revisions\/134046"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/obera.fr\/lt\/wp-json\/wp\/v2\/media\/83744"}],"wp:attachment":[{"href":"https:\/\/obera.fr\/lt\/wp-json\/wp\/v2\/media?parent=134044"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/obera.fr\/lt\/wp-json\/wp\/v2\/categories?post=134044"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/obera.fr\/lt\/wp-json\/wp\/v2\/tags?post=134044"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}